Sr. Quality Engineering Technician

Resumen

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

 

The Senior Quality Technician provides hands-on quality support for NPI and transfer activities, with a strong focus on in-process audits during ramp-up, inspection support, documentation review, and routine quality execution. This role supports Senior Quality Engineers, Quality Engineers, NPI Engineers, and cross-functional teams to help move products and processes into controlled manufacturing. The position also serves as a practical day-to-day resource for data collection, nonconformance support, inspection follow-up, and quality system execution.

 

 

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsabilidades

• Perform incoming, in-process, and final inspection activities for NPI and transferred products.
• Conduct in-process audits during ramp-up to verify compliance with procedures, control plans, and inspection criteria.
• Support Quality Engineers with data collection, sample preparation, documentation review, and execution of IQ, OQ, PQ, process characterization, and TMV activities.
• Assist with review and organization of manufacturing, supplier, and transfer documentation packages.
• Support Gage R&R studies, measurement checks, and validation data collection as directed.
• Document nonconformances, deviations, and related quality records, and support follow-up actions as assigned.
• Support audit readiness layered process audits, internal audits, and customer or regulatory audit preparations.
• Assist in troubleshooting ramp-up and production issues by collecting data, identifying gaps, and escalating concerns to engineers.
• Support quality control plans, calibration checks, fixture verification, and maintenance of quality records.
• Collaborate with Quality Systems on CAPAs, NCRs, training records, document control, and complaint-related documentation as needed.
• Provide hands-on support to production, NPI, and transfer teams during ramp-up to help stabilize processes and improve first-pass quality.

Perform additional duties and special projects as assigned by the manager.

Calificaciones

• Quality technician degree or associate degree.
• Minimum 2 years of experience in quality control, inspection, manufacturing support, or a related role in a regulated environment.
• Direct hands-on experience supporting NPI, product transfers, process transfers, process validation, or manufacturing scale-up.
• Experience with visual and dimensional inspection, microscope use, and measurement equipment.
• Ability to read work instructions, procedures, and basic technical documentation.
• Strong attention to detail, organization, communication, and follow-up.
• Ability to work under minimal supervision and support multiple priorities.
• Basic working knowledge of Microsoft Office applications.
• Professional working English, written and spoken, sufficient to follow instructions and communicate clearly with the team.

Valid U.S. visa in good standing and ability to travel to the United States as business needs require.

Cualificaciones requeridas

• Medical device manufacturing background preferred.
• Experience supporting NPI, transfers, ramp-up, in-process audits, or quality system activities.
• Familiarity with ISO 13485, FDA requirements, CAPA, NCR, and document control is desirable.
• Certified Quality Technician, Six Sigma Green Belt, Six Sigma Yellow Belt, or equivalent quality/statistical certification.
• Experience with catheter-based devices, minimally invasive devices, complex assemblies, Class II / Class III medical devices, and/or manufacturing components and processes related to Nitinol.
• Experience with customer-to-site, site-to-site, or line transfer projects.

Experience in contract manufacturing or customer-facing medical device operations.